NEOTECH PRODUCTS

Description of Event or Problem

DEVICE GOT HOT AND ALLEGEDLY CAUSED SMALL ABRASION ON LATERAL ASPECT.

Additional Manufacturer Narrative

THIS IS OUR RESPONSE TO THE REPORT NUMBER (B)(4) REPORTED BY HOSPITAL AND FORWARDED TO US BY FDA. DEVICE WAS NOT RETURNED AND NO EVALUATION WAS POSSIBLE ON THE ACTUAL DEVICE. HOWEVER, THE PRODUCT'S DEVICE HISTORY RECORDS (DHR) OF THE CURRENT INVENTORY WERE REVIEWED AND NO NONCONFORMITY WAS FOUND. SAMPLES OF FINISHED GOODS WERE PULLED OUT FROM RETAINED SAMPLES OF THE CURRENT LOT NUMBER FOR RE-INSPECTION AND NO ABNORMALITY WAS FOUND. THE FUNCTIONALITY OF POWER BUTTON WAS VERIFIED AND THERE WERE NO ISSUES WITH THE PRODUCT. BASED ON THE PROVIDED INFORMATION WE WERE NOT ABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED INCIDENT. SINCE THE REPORT INDICATED BROKEN CASE AND HISTORY OF DIFFICULTY IN TURNING OFF, IT CAN'T BE RULED OUT THAT THE PRODUCT HAD BEEN DROPPED SEVERAL TIMES PRIOR TO THE INCIDENT AND CAUSED THE ISSUE. THIS WAS AN ISOLATED INCIDENT FOR NEOGLO AND WE DID NOT HAVE ANY SIMILAR INCIDENT FOR THIS DEVICE IN LAST TWO YEARS. WE WERE NOT ABLE TO REPRODUCE THE ISSUE WITH RETAINED SAMPLES OR CONFIRM THE CAUSE OF THIS ISOLATED INCIDENT AS ALL THE RETAINED AND CURRENT SAMPLES OF THE PRODUCT FUNCTIONED AS EXPECTED. THIS COMPLAINT WILL BE MONITORED FOR TRENDING PURPOSES AND IS ADDED TO THE RELATED LOGS AND CHARTS.